Silk Voice (SMI-04)
FDA 510(k) K240919 · Sofregen Medical
510(k) numberK240919
Submission
- Device name
- Silk Voice (SMI-04)
- Applicant
- Sofregen Medical
Framingham, MA, US - Received
- April 3, 2024
- Decision date
- May 3, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MIX – System, Vocal Cord Medialization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
Other 510(k)s with product code MIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180631 | Silk VoiceMIX · Traditional | Sofregen Medical, Inc. | 11/08/2018SE |
| K150400 | Renu GelMIX · Special | Cytophil, Inc. | 04/06/2015SE |
| K121795 | Calcium Hydroxylapatite Vocal Fold ImplantMIX · Traditional | Cytophil, Inc. | 02/22/2013SE |
| K083783 | VF LiquigelMIX · Traditional | Coapt Systems, Inc. | 09/11/2009SE |
| K081816 | Vocalis and Vocalis SMMIX · Traditional | Cytophil, Inc. | 01/05/2009SE |
| K081815 | Vocalis GelMIX · Traditional | Cytophil, Inc. | 01/05/2009SE |
| K080956 | Modification to VF Gel PlusMIX · Special | Coapt Systems, Inc. | 04/25/2008SE |
| K071663 | VF Gel PlusMIX · Traditional | Coapt Systems, Inc. | 02/15/2008SE |
| K070090 | Radiesse Laryngeal ImplantMIX · Special | Bioform Medical, Inc. | 03/01/2007SE |
| K060815 | Juliesse Injectable Laryngeal Augmentation ImplantMIX · Special | Bioform Medical, Inc. | 04/18/2006SE |
More from Bioform Medical, Inc.
Questions and answers
When was Silk Voice (SMI-04) cleared by the FDA?
Silk Voice (SMI-04) (K240919) received a 510(k) decision of Substantially Equivalent on May 3, 2024, 30 days after the submission was received.
What is the product code of K240919?
The FDA product code is MIX – System, Vocal Cord Medialization, a Class II (moderate risk) device regulated under 21 CFR 874.3620.